MAUDE Adverse Event Report: COVIDIEN (IRVINE) SILVERHAWK BTK; CATHETER, PERIPHERAL, ATHERECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Embolism (1829); Perforation (2001); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

Article title: acute results of directional atherectomy for the treatment of claudication and critical limb ischemia in the definitive le study reference: vascular disease management 2017;14(2):e21-e33 a2: patient mean age was 70 years a3: 54.6% of the population was male.

Event Description

This study was a multi-center, single-arm, non-randomized study designed to evaluate the acute and long-term safety and effectiveness of da for endovascular treatment of pad in femoropopliteal and tibial-peroneal arteries.Enrollment occurred between april, 2009 and april, 2011 at 47 international centers.Eight hundred subjects were enrolled in the study; however, inadequate informed consent resulted in the exclusion of one subject¿s data from all analyses.The mean age was 70.1 ± 10.7 years and 45.4% of the population was female.All subjects underwent percutaneous revascularization of the femoropopliteal and/or tibial-peroneal arteries using either a silverhawk or turbohawk directional atherectomy device.In cases in which the da device was unable to cross, the lesions were permitted to be pre-dilated.The need for pre-dilation to facilitate the passage and use of an atherectomy device occurred in 9% of lesions.After initial therapy with da, adjunctive therapy was performed in 35.3% of the target lesions.The majority of adjunctive therapy was pta; the adjunctive stent rate was 3.2%.Distal embolic protection (dep) via a filter device was used in 22.2% of subjects, with the spider fx embolic protection system used in 97.2% of those cases.Follow-up assessments occurred prior to discharge and at 30 days, 3 months (for subjects with rcc score 5 or 6 at baseline), 6 months, and 1 year following the index procedure.Peri-procedural events noted were distal embolization, abrupt closure, flow limiting dissection, perforation and aneurysm.Distal embolization occurred in 30 cases, with 1 requiring surgical intervention, 1 stenting and 11 pta.Dissection occurred in 18 cases with 8 requiring stenting and 4 pta.Peroration occurred in 42 cases with 1 requiring surgical intervention, 15 stenting and 17 pta.All perforation events were associated with wire passage, da use, or adjunctive therapy to include pta and/or stenting.Aneurysm occurred in 3 cases with 2 requiring stenting.Abrupt closure occurred in 15 cases associated to dissection, embolization, thrombosis and perforation.12 closures required treatment with 8 requiring surgical intervention, 1 stenting and 3 pta.The 30-day mae rate was 1.6% including 4 deaths, 6 clinically driven target-lesion revascularizations, and 3 major unplanned amputations; 1 above the knee, 1 below the knee, and 1 syme¿s).None of the 4 deaths within 30 days were adjudicated as related to either the study device or the index procedure by the cec (3 were due to myocardial infarction and 1 was due to cardiogenic shock).

• Brand Name: SILVERHAWK BTK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6686350
• MDR Text Key: 79059120
• Report Number: 2183870-2017-00285
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR